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Quality & Validation Systems Specialist (Pharma)

3 meses atrás

Lisboa, Lisboa, Portugal Hovione Tempo inteiro

Join a Market Leader

Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

You will be responsible to:

Defines and implements procedures and processes to assure that Hovione Computerized systems are fit for purpose and comply with applicable quality and data integrity standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and data integrity requirements to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying best practices.

Test all computerized systems to demonstrate its compliance with internal and external guidelines (such as 21CFR Part 11, GAMP, EU, PIC/s and ICH) Participate in project teams that require expertise in Computerized Systems. Apply a risk-based approach throughout the life cycle of the Computerized Systems taking into account patient safety, data integrity and product quality Implement the defined policies for Computerized Systems life cycle Management Perform validation activities of the Computerized System projects and provide the necessary guidance to ensure compliance with Regulatory and Industry Standards throughout systems' life cycle Implement data integrity principles during the Computerized System life cycle, as defined Collaborate in the definition of the required Qualification and Validation strategies for different Computerized Systems: Analytical equipment, Manufacturing equipment, DCS, PLC and other stand-alone software Issue, review and approve protocols and reports (i.e., DQ, IQ, OQ and PQ), relating to the Validation of Computerized Systems and other validation/qualification documents Review/approve/close corporate Computerized System change controls, deviations, incidents submitted by any Department/Site, to ensure that the system is maintained in an accurate, validated, and compliant state Review/approve documentation regarding Computerized Systems data integrity and its life cycle management Provide training and coaching in quality culture and data integrity principles regarding Computerized Systems. Support internal, external/ customers' audits and health authorities' inspections. Perform assigned tasks as planned and deliver on time, safely, efficiently, reliably and in a cost-effective manner Propose improvements to the area as appropriate and solve problems Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione ́s policies, systems and procedures (COPs, HBR, SOPs and others)

We are looking to recruit a Candidate:

BSc / BEng, MSc / MEng, PhD in chemical engineering or equivalent. Min 3-5 years' relevant experience in Computerized Systems Validation/Testing and/or Data Integrity within the pharmaceutical industry (GMP/GAMP experience is mandatory) Experience in technical manufacturing support. Strong understanding and knowledge of: Software testing Quality systems and validation principles Computerized Systems Validation Data Integrity Principles GAMP 5 Guide: Compliant GxP Computerized Systems, cGMP, ICH and ISO guidelines Risk Assessment applied to Computerized Systems Life Cycle Result driven, team player, able to deal with multiple projects/tasks. Ability to interact with and be part of multi-disciplinary teams.